Devices, systems, and methods for the prevention of stroke

ABSTRACT

The disclosure of the present application provides devices, systems, and methods for the prevention of stroke. In at least one embodiment of a device of the present application, the device comprises an extension portion sized and shaped to fit within an artery extending from an aortic arch, and a flange portion sized and shaped to prevent the device from advancing into the artery extending from the aortic arch in which the device may be positioned. In at least one embodiment of a system for preventing stroke of the present application, the system comprises a hypotube, a folder coupled to a distal end of the hypotube, a sleeve positioned circumferentially around the hypotube proximal to the folder, and a stent, wherein a first part of the stent may be positioned within the folder, and wherein a second part of the stent may be positioned within the sleeve.

PRIORITY

This international application is related to, and claims the prioritybenefit of, U.S. Patent Application Ser. No. 61/169,767, filed Apr. 16,2009, the entire contents of which are hereby incorporated by referencein their entirety into this disclosure.

BACKGROUND Stroke

A stroke is defined as a rapidly developing loss of brain function dueto a disturbance in the blood supply to the brain. This can be due toischemia (lack of blood supply) caused by thrombosis or embolism or dueto a hemorrhage. As a result, the affected area of the brain is unableto function, leading to the inability to move one or more limbs on oneside of the body, the inability to understand or formulate speech, orthe inability to see one side of the visual field amongst others.

Each year, about 800,000 people experience a new or recurrent stroke.Approximately 600,000 of these are first attacks, and 200,000 arerecurrent attacks. In addition, and on average, someone in the U.S. hasa stroke every 40 seconds, and each year, about 55,000 more women thanmen have a stroke. On average, every 3-4 minutes, someone dies of astroke. Because women live longer than men, more women than men die ofstroke each year. Women accounted for 60.6% of U.S. stroke deaths in2005. Men stroke incidence rates are greater than women at younger agesbut not at older ages. Despite advances in stroke prevention treatments,the incidence of hospitalized stroke and case fatality did not decrease.African-Americans have almost twice the risk of first-ever stroke thanwhites. The age adjusted stroke incidence rates in people 45-84 years ofage are 6.6 per 1000 population in black men, 3.6 in white men, 4.9 inblack women, and 2.3 in white women.

Of all strokes, 87% are ischemic, 10% are intracerebral hemorrhage, and3% are subarachnoid hemorrhage strokes. Stroke accounted for about 1 outof every 17 deaths in the U.S. in 2005, and approximately 53% of strokedeaths in 2005 occurred out of the hospital.

Total stroke mortality in 2005 was about 150,000. The 2005 overall deathrate for stroke was 46.6 per 100,000. Death rates were 44.7 for whitemales, 70.5 for black males, 44.0 for white females, and 60.7 for blackfemales, all per 100,000. When considered separately from othercardiovascular diseases, stroke ranks no. 3 among all causes of death,behind heart disease and cancer.

A report released by the Centers for Disease Control (CDC) incollaboration with the Centers for Medicare and Medicaid Services (CMS),the Atlas of Stroke Hospitalizations Among Medicare Beneficiaries, foundthat in Medicare beneficiaries, 30-day mortality rate varied by age: 9%in patients 65 to 74 years of age, 13.1% in those 74 to 84 years of age,and 23% in those ≧85 years of age.

Atrial Fibrillation

Atrial fibrillation (AF) is an significant, independent risk factor forischemic stroke, increasing risk about 5-fold. The percentage of strokesattributable to AF increases steeply from 1.5% at 50 to 59 years of ageto 23.5% at 80 to 89 years of age. Most strokes in patients with AF arecardioembolic caused by embolism of left atrial appendage thrombi, butsome are caused by coexisting intrinsic cerebrovascular diseases intypically elderly, often hypertensive patients.

AF carries an annual risk of thromboembolic complications of 3-6%, whichis 5-7 times greater than that of controls with sinus rhythm. AF ispresent in 15-21% of patients affected by stroke. AF/flutter, a strongrisk factor for stroke, is arguably the most important finding oncardiac workup in patients with ischemic stroke. Once identified,introduction of oral anticoagulant therapy (warfarin, for example)provides a 40% risk reduction in recurrent stroke compared withantiplatelet therapy. Ischemic stroke with AF is associated with greaterdisability and mortality than those without AF.

Patients with AF have an increased risk of major, disabling stroke,often caused by large infarctions in the middle cerebral arteryterritory. Some studies showed that AF was associated with an increasedrisk of death in the first four weeks after stroke likely due to theadvanced age in stroke patients with AF, large infarction, severeneurological deficits, and poor functional outcomes.

First, strokes in patients with AF may largely be cardioembolic, whichcauses a sudden occlusion of large cerebral arteries without sufficientcollateral blood flow, resulting in more severe strokes. Several studieshave reported that stroke patients with AF often have large corticalinfarcts on computed tomography, and less frequently have lacunarinfarction as compared with patients without AF.

Heart Failure

Patients with heart failure (HF) are at increased risk forthromboembolic events. Left ventricular (LV) thrombus provides asubstrate for events and a rationale for anticoagulation.Echocardiography studies have yielded conflicting results, however,regarding thrombus prevalence. Among populations with similar degrees ofsystolic dysfunction, studies have reported over a 20-fold difference inprevalence, ranging from 2.1% to 50%. Moreover, when thrombus isidentified, conflicting findings have been reported concerning the riskof future embolic events.

The impact of nonrheumatic atrial fibrillation, hypertension, coronaryheart disease, and cardiac failure on stroke incidence was examined inthe Framingham Study. Compared with subjects free of these conditions,the age-adjusted incidence of stroke was more than doubled in thepresence of coronary heart disease and more than tripled in the presenceof hypertension. There was a more than fourfold excess of stroke insubjects with HF and nearly fivefold increase when atrial fibrillationwas present. In persons with coronary heart disease or HF, atrialfibrillation doubled the stroke risk in men and tripled the risk inwomen. Factors that predispose to thromboembolic events in patients withHF include low cardiac output, with relative stasis of blood in dilatedcardiac chambers, poor contractility and regional wall motionabnormalities and concomitant atrial fibrillation.

BRIEF SUMMARY

In at least one exemplary embodiment of a device for the prevention ofstroke of the present disclosure, the device comprises an extensionportion sized and shaped to fit within an artery extending from anaortic arch, and a flange portion sized and shaped to prevent the devicefrom advancing into the artery extending from the aortic arch in whichthe device may be positioned, the flange portion comprising two or moreparallel convex struts positioned across an opening defined within theflange portion, the two or more parallel convex struts capable ofdiverting an embolus from entering the artery when the device ispositioned within the artery. In another embodiment, the two or moreparallel convex struts comprises four or more parallel convex struts. Inan exemplary embodiment, when the device is positioned within the arteryextending from an aortic arch, the two or more parallel convex strutsare positioned either approximately perpendicular to, or in a directionof, blood flow within the aortic arch. In an additional embodiment, thedevice comprises a stent. In yet an additional embodiment, the stent isautoexpandable.

In at least one exemplary embodiment of a device for the prevention ofstroke of the present disclosure, the extension portion comprises asubstantially cylindrical shape. In another embodiment, the extensionportion comprises an extension mesh comprising multiple wires. In yetanother embodiment, the extension portion has a length between about 1.5cm to about 2.5 cm. In an additional embodiment, the extension portionhas a diameter between about 6 mm to about 8 mm when the extensionportion is in an expanded configuration. In yet an additionalembodiment, the extension portion has a diameter between about 1.8 mm toabout 2.0 mm when the extension portion is in a compressedconfiguration.

In at least one exemplary embodiment of a device for the prevention ofstroke of the present disclosure, the device is comprised of a materialselected from the group consisting of stainless steel,cobalt-chromium-nickel-molybdenum-iron alloy, tantalum, nitinol,nickel-titanium, polymer materials, and a shape-memory polymer. In anadditional embodiment, the flange portion comprises a flange meshcomprising multiple wires. In another embodiment, the flange portioncomprises a planar flange.

In at least one exemplary embodiment of a device for the prevention ofstroke of the present disclosure, the device further comprises one ormore radiopaque markers positioned upon the flange portion. In anadditional embodiment, the one or more radiopaque markers are positionedrelative to the two or more parallel convex struts. In yet additionalembodiments, when the device positioned within the artery extending froman aortic arch, the one or more radiopaque markers facilitate alignmentof the device so that the two or more parallel convex struts arepositioned either approximately perpendicular to, or in a direction of,blood flow within the aortic arch.

In at least one exemplary embodiment of a device for the prevention ofstroke of the present disclosure, the diameter of each of the two ormore parallel convex struts is between about 0.25 mm and 0.5 mm. Inanother embodiment, the two or more parallel convex struts arepositioned between about 0.5 mm to 1.5 mm from one another. In yetanother embodiment, the two or more parallel convex struts are flexible.

In at least one exemplary embodiment of a device for the prevention ofstroke of the present disclosure, the device comprises an extensionportion sized and shaped to fit within an artery extending from anaortic arch, and a flange portion sized and shaped to prevent the devicefrom advancing into the artery extending from the aortic arch in whichthe device may be positioned, the flange portion capable of diverting anembolus from entering the artery extending from the aortic arch when thedevice is positioned within the artery. In an additional embodiment, thedevice further comprises one or more radiopaque markers positioned uponthe flange portion. In yet an additional embodiment, the device furthercomprises two or more convex parallel struts positioned across anopening defined with the flange portion, wherein the one or moreradiopaque markers are positioned relative to the two or more parallelconvex struts. In another embodiment, when the device positioned withinthe artery extending from an aortic arch, the one or more radiopaquemarkers facilitate alignment of the device so that the two or moreparallel convex struts are positioned either approximately perpendicularto, or in a direction of, blood flow within the aortic arch.

In at least one exemplary embodiment of a device for the prevention ofstroke of the present disclosure, the device further comprises two ormore parallel convex struts positioned across an opening defined withthe flange portion.

In at least one exemplary embodiment of a device for the prevention ofstroke of the present disclosure, the device comprises an extensionportion comprising a substantially cylindrical shape, the extensionportion sized and shaped to fit within an artery extending from anaortic arch, a flange portion sized and shaped to prevent the devicefrom advancing into the artery extending from the aortic arch in whichthe device may be positioned, the flange portion comprising two or moreparallel convex struts positioned across an opening defined within theflange portion, the two or more parallel convex struts capable ofdiverting an embolus from entering the artery when the device ispositioned within the artery, and one or more radiopaque markerspositioned upon the flange portion, wherein when the device positionedwithin the artery extending from an aortic arch, the one or moreradiopaque markers facilitate alignment of the device so that the two ormore parallel convex struts are positioned either approximatelyperpendicular to, or in a direction of, blood flow within the aorticarch.

In at least one exemplary embodiment of a system for preventing strokeof the present disclosure, the system comprises a device for theprevention of stroke, the device comprising an extension portion sizedand shaped to fit within an artery extending from an aortic arch, and aflange portion sized and shaped to prevent the device from advancinginto the artery extending from the aortic arch in which the device maybe positioned, the flange portion comprising two or more parallel convexstruts positioned across an opening defined within the flange portion,the two or more parallel convex struts capable of diverting an embolusfrom entering the artery when the device is positioned within theartery, a hypotube having a distal end and a proximal end, a foldercoupled to the distal end of the hypotube, the folder sized and shapedto receive at least a portion of the device for the prevention ofstroke, and a sleeve positioned circumferentially around the hypotubeproximal to the folder, the sleeve sized and shaped to receive at leasta portion of the device for the prevention of stroke. In anotherembodiment, the system further comprises a conical dilator, the conicaldilator sized and shaped to slidingly engage the hypotube. In yetanother embodiment, the conical dilator comprises a tapered distal and aproximal end. In an additional embodiment, the folder has an innerdiameter, and wherein the tapered distal end of the conical dilator issized and shaped to fit within the inner diameter of the folder. In yetan additional embodiment, when the device is positioned within theartery extending from an aortic arch, the two or more parallel convexstruts either approximately perpendicular to, or in a direction of,blood flow within the aortic arch.

In at least one exemplary embodiment of a system for preventing strokeof the present disclosure, the device of the system comprises a stent.In another embodiment the stent is autoexpandable. In yet anotherembodiment, the hypotube has an aperture defined therethrough from thedistal end to the proximal end of the hypotube, said aperture sized andshaped to slidingly receive a guidewire.

In at least one exemplary embodiment of a method for preventing strokeof the present disclosure, the method comprises the steps of introducinga first stent having two or more convex struts into a body, navigatingthe first stent within the body until the first stent reaches an aorticarch, and positioning the first stent within a first vessel branchingfrom the aortic arch so that the two or more convex struts arepositioned either approximately perpendicular to, or in a direction of,blood flow within the aortic arch. In another embodiment, the step ofintroducing a first stent having two or more convex struts into a bodycomprises introducing a device for preventing stroke into a body, thedevice comprising an extension portion sized and shaped to fit withinthe vessel extending from the aortic arch, and a flange portion sizedand shaped to prevent the device from advancing into the arteryextending from the aortic arch in which the device may be positioned,the flange portion comprising the two or more parallel convex strutspositioned across an opening defined within the flange portion, thestruts capable of diverting an embolus from entering the artery when thedevice is positioned within the artery. In yet another embodiment, thestep of positioning the first stent is performed by aligning the firststent within the vessel by detecting one or more radiopaque markerspositioned upon the first stent. In an additional embodiment, the stepof positioning the first stent comprises positioning the first stentwithin an innominate artery.

In at least one exemplary embodiment of a method for preventing strokeof the present disclosure, the method further comprises the steps ofintroducing a second stent having two or more convex struts into thebody; navigating the second stent within the body until the second stentreaches the aortic arch, and positioning the second stent within asecond vessel branching from the aortic arch so that the two or moreconvex struts of the second stent are positioned either approximatelyperpendicular to, or in a direction of, blood flow within the aorticarch. In another embodiment, the step of positioning the second stentcomprises positioning the second stent within a common carotid artery.In yet another embodiment, the step of positioning the first stentcomprises positioning the first stent within an innominate artery,wherein the first stent is capable of diverting an embolus from enteringthe innominate artery, and wherein the second stent is capable ofdiverting the embolus from entering the common carotid artery.

In at least one exemplary embodiment of a method for preventing strokeof the present disclosure, the method comprises the steps of introducinga wire into a body via a body puncture, the wire having a distal end,navigating the wire within the body until the distal end of the wirereaches a desired location within an aorta, mounting at least a portionof a system for preventing stroke over the guidewire, the systemcomprising a hypotube having a distal end and a proximal end, a foldercoupled to the distal end of the hypotube, the folder sized and shapedto receive at least a portion of a stent, a sleeve positionedcircumferentially around the hypotube proximal to the folder, the sleevesized and shaped to receive at least a portion of the stent, and astent, wherein a first part of the stent is positioned within thefolder, and wherein a second part of the stent is positioned within thesleeve, advancing at least a portion of the system for preventing strokewithin the body until the distal end of the hypotube is positionedwithin an artery branching from the aorta, and deploying the stentwherein at least a portion of the stent is positioned within the arteryand wherein at least a portion of the stent is positioned within theaorta. In another embodiment, the step of deploying the stent comprisesthe step of pulling the sleeve away from the stent to deploy the firstportion of the stent. In yet another embodiment, the step of deployingthe stent further comprises the step of advancing the hypotube into theartery to deploy the second portion of the stent. In an additionalembodiment, the step of deploying the stent further comprises the stepadvancing a conical dilator comprising a tapered distal end along thehypotube so that the tapered distal end of the conical dilator engagesthe folder. In an additional embodiment, the method further comprisesthe step of withdrawing the portion of the system within the body fromthe body.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a diagram of at least a portion of an aorta, according tothe present disclosure;

FIGS. 2A and 2B show exemplary embodiments of a device for theprevention of stroke, according to the present disclosure;

FIG. 2C shows an embodiment of a device comprising a planar flange,according to the present disclosure;

FIG. 3A shows exemplary devices for the prevention of stroke positionedwithin arteries extending from a portion of an aorta with the convexstruts in alignment with blood flow, according to the presentdisclosure;

FIG. 3B shows exemplary devices for the prevention of stroke positionedwithin arteries extending from a portion of an aorta with the convexstruts in alignment approximately perpendicular to blood flow, accordingto the present disclosure;

FIG. 4 shows an exemplary embodiment of a system for preventing stroke,according to the present disclosure;

FIGS. 5A and 5B show an exemplary system of the present disclosure withportions thereof being moved to allow for device deployment, accordingto the present disclosure;

FIGS. 6A and 6B show at least a portion of an exemplary system forpreventing stroke, said system comprising a conical dilator useful tofacilitate removal of at least a portion of the exemplary system fromthe body, according to the present disclosure;

FIGS. 7A and 7B show additional embodiments of an exemplary system forpreventing stroke, according to the present disclosure; and

FIGS. 8A-8E show various steps of a method for positioning a devicewithin a body, according to the present disclosure.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It will nevertheless be understood that no limitationof the scope of this disclosure is thereby intended.

The disclosure of the present application provides various devices,systems, and methods for the prevention of stroke. The devices, systems,and methods disclosed herein facilitate stroke prevention, in part, byaddressing specific areas of the heart.

A diagram of at least a portion of an exemplary aorta is shown inFIG. 1. An aorta 100 is the main trunk of a vascular system whichconveys oxygenated blood to the tissues of a body. It begins at theupper part of the left ventricle, where it may be approximately 3 cm indiameter in an adult human. As shown in FIG. 1, and at the union of theascending aorta 102 with the aortic arch 104 (or the “arch of aorta”),the caliber of the vessel is increased, owing to a bulging of its rightwall. This dilatation is termed the aortic bulb 106 (or bulb of theaorta), and on transverse section shows a somewhat oval figure. Theascending aorta 102 is contained within the pericardium, and is enclosedin a tube of the serous pericardium. It ascends for a short distance(the ascending aorta 102 is about 5 cm in length in an adult human),arches backward, and then descends within the thorax and abdomen (thedescending aorta 108) and ends into the right and left common iliacarteries (about 1.7 cm in diameter in an adult human). The rightcoronary 110 and the left coronary 112, as shown in FIG. 1, branch fromthe ascending aorta 102.

There are three arteries that branch from the aortic arch 104, namelythe innominate artery 114, the left common carotid artery 116, and theleft subclavian artery 118. Instead of arising from the highest part ofthe aortic arch 104, these branches may spring from the commencement ofthe aortic arch 104 or the upper part of the ascending aorta 102. Thedistance between the aortic arch 104 or the upper part of the ascendingaorta 102 at their origins may be increased or diminished, the mostfrequent variation being the approximation of the left common carotidartery 116 toward the innominate artery 114. In addition, and as shownin FIG. 1, the innominate artery 114 branches into the right subclavianartery 120 and the right common carotid artery 122.

FIGS. 2A-2C show exemplary embodiments of a device of the presentapplication for the prevention of stroke. As shown in FIG. 2A, anexemplary device 200 may comprise a stent comprising an extensionportion 202 and a flange portion 204. Extension portion 202, as shown inFIG. 2A, may comprise a cylindrical stent sized and shaped to fitsecurely within an aortic branch. An exemplary extension portion 202 maycomprise, for example, extension mesh 206 comprising multiple wires asshown in FIG. 2A. Flange portion 204 may comprise an inner diameter(shown as D1 in FIG. 2A) and an outer diameter (shown as D2), whereby D2is larger than D1. In at least one embodiment, device 200 iscollapsible, similar to a traditional stent.

In at least one embodiment of device 200 of the disclosure of thepresent application, device 200 comprises an autoexpandable metallicstent comprising a proximal flange (flange portion 204) and a distalcylindrical tube (extension portion 202). In an exemplary embodiment,extension portion 202 is approximately 1.5 cm to 2.5 cm in length. In atleast one embodiment of device 200, the diameter of the stent isapproximately 6 to 8 mm. Suitable material for a device 200 includes butis not limited to, stainless steel,cobalt-chromium-nickel-molybdenum-iron alloy, tantalum, nitinol,nickel-titanium, polymer materials, and various shape-memory polymersknown in the art, including polyurethane, polytetrafluoroethylene orpolytetrafluoroethene (PTFE), or another synthetic material.

Flange portion 204, as shown in the exemplary embodiments shown in FIGS.2A and 2B, comprises flange mesh 208 comprising multiple wires. Inanother embodiment, and as shown in FIG. 2C, flange portion 204comprises a planar flange 210 comprised of metal, plastic, or any othermaterial suitable for such a flange portion 204.

As shown in FIGS. 2A-2C, flange portion 204 also comprises a pluralityof convex struts 212 operable to divert, for example, an embolus, fromentering the inner portion of device 200 (the inner portion defined byextension portion 202). Convex struts 212 are one example of such anembolus diversion portion of device 200, noting that other embodimentsof an embolus diversion not comprising convex struts 212 may be usefulwith device 200. For example, and instead of convex struts 212, anexemplary embolus diversion portion may comprise a mesh (similar to, forexample, extension mesh 206 and/or flange mesh 208), whereby such a meshis operable to divert an embolus from entering the inner portion ofdevice 200.

Convex struts 212, in an exemplary embodiment, are positioned alongdevice 200 to cover the proximal orifice of the cylindrical stent(device 200). In at least one embodiment of a device 200 of thedisclosure of the present application, the diameter of each convex strut212 is approximately 0.25 mm to 0.5 mm, and the distance between eachconvex strut 212 is approximately 0.5 mm to 1.5 mm. Convex struts 212may comprise material the same and/or similar to the material used toprepare other portions of device 200, and may also be a combination of ametal plus polyurethane, polytetrafluoroethylene orpolytetrafluoroethene (PTFE), or another synthetic material.

In at least one embodiment, convex struts 212 may be semirigid orflexible in order to allow the removal of hypotube 402 (see FIG. 4)and/or allow the passage of a catheter stent device, including device200, for stenting the carotid artery, for example, if it develops anatherosclerotid plaque. In an exemplary embodiment, the strut shape canbe convex or semiconvex in order to be easily and constantly “washed” bythe aortic blood flow and therefore avoid local thrombosis. If an embolilands on a strut, the strut shape will also allow it to wash off to theperiphery.

In addition, and in the exemplary embodiment shown in FIG. 2B, device200 may further comprise one or more radiopaque markers 214 are locatedproximally and/or distally on device 200 to aid the placement of device200 within a body.

Exemplary devices for the prevention of stroke positioned within aportion of an aorta are shown in FIGS. 3A and 3B. As shown in FIGS. 3Aand 3B, two devices 200 are shown positioned within arteries branchingfrom aorta 100, with one device 200 positioned partially withininnominate artery 114 and another device 200 positioned partially withinleft common carotid artery 116. Device 200 positioned within innominateartery 114 is positioned so that extension portion 202 is positionedwithin a portion of innominate artery 114 extending from aortic arch104, and whereby flange portion 204 prevents device 200 from advancingfurther into innominate artery 114. Similarly, a device 200 is shown inFIGS. 3A and 3B positioned within left common carotid artery 116, sothat extension portion 202 is positioned within a portion of left commoncarotid artery 116 extending from aortic arch 104, and whereby flangeportion 204 prevents device 200 from advancing further into left commoncarotid artery 116. In at least one embodiment, flange portion 204completely covers and exceeds the entrance of the artery in which device200 is positioned. In an exemplary embodiment of device 200 positionedwithin an artery as referenced herein, the distal cylindrical portion ofthe stent (extension portion 202 of device 200) anchors device 200 byway of radial force within the artery for which device 200 is placed.

As shown in the exemplary embodiments of device 200 shown in FIG. 3A,convex struts 212 are aligned in a direction similar to the flow ofblood within aorta 100. In such an alignment, and as blood flows throughaorta 100, an embolus 300 which may be present within aorta 100(specifically within the aortic arch 104) would be guided along convexstruts 212. As shown in FIG. 3B, devices 200 are aligned in a directionapproximately perpendicular to the flow of blood within aorta 100. Insuch an alignment, an embolus 300 present within aorta 100 wouldpotentially contact convex struts 212 and be deflected therefrom withlittle or no risk of embolus 300 being trapped therein.

As shown in FIGS. 3A and 3B, an embolus 300 is prevented from enteringthe innominate artery 114 and the left common carotid artery 116, but ispermitted to enter the left subclavian artery 118. As such, and in thisexample, an embolus 300 present within the aorta is effectivelyprohibited from being advanced to the brain, as an embolus 300 cannotenter the innominate artery 114 and the left common carotid artery 116because devices 200 are positioned within each of those arterialopenings. Such an arrangement of devices 200 may then effectivelyprevent a patient from having a stroke based upon the introduction of anembolus 300 from the aortic arch 104 to the brain.

In summary, and as described above with respect to FIGS. 3A and 3B, forexample, the disclosure of the present application provides a device200, which may be referred to as a percutaneous carotid emboli reroutingdevice, to be delivered individually to arteries given off by the aorticarch (namely the innominate artery 114, the left common carotid artery116, and the left subclavian artery 118) in order to avoid the passageof the embolic or thromboembolic material (an embolus 300, which may be,for example, a clot, calcium, etc.) to the vascular brain system. Suchan arrangement of devices 200 would then prevent thromboembolic strokein patients with different cardiovascular diseases from cardiac origin.

At least one goal of the devices, systems, and methods of the presentdisclosure is to reroute an embolus distally to the arterial system(iliac or femoral arteries) to avoid disabling stroke, decreasemortality and avoid physical impairment with a poor quality of life.Unlike stroke, medical or surgical treatment of the peripheral arterialembolus (fibrinolitic drugs, surgical embolectomy, or endovascularembolus suction) can be provided with little residual effects.

An exemplary embodiment of a system for preventing stroke of the presentdisclosure is shown in FIG. 4. As shown in FIG. 4, system 400 comprisesa hypotube 402 having a distal end and a proximal end, and in at leastone exemplary embodiment, hypotube 402 comprises a folder 404 coupled tothe distal end of hypotube 402. In the embodiment shown in FIG. 4,system 400 further comprises a device 200, whereby an extension portion202 of device 200 is shown positioned within at least part of folder404, and whereby a flange portion 204 of device 200 is positioned withinat least part of a sleeve 406 positioned around hypotube 402 proximal tofolder 404. Sleeve 406, as shown in this exemplary embodiment, slidinglyengages hypotube 402 and may be moved in a forward or backward directionas indicated by the arrow in the figure.

In at least one embodiment, device 200 is an autoexpandable metallicstent mounted over a hypotube 402 as shown in FIG. 4. Device 200 may becompressed by sleeve 406 and folder 404. In at least one embodiment, atleast part of system 400 has a diameter of 7 Fr to 8 Fr (2.3 to 2.7 mm),with an exemplary device 200 having a compressed diameter of about 1.8to 2.0 mm.

FIGS. 5A and 5B show exemplary embodiments of at least portions ofsystems for preventing stroke of the present disclosure. As shown inFIG. 5A, an exemplary system 400 comprises hypotube 402 to which folder404 is coupled thereto. System 400, as shown in FIGS. 5A and 5B, furthercomprises sleeve 406 slidingly engaged around hypotube 402. Device 200may be positioned at least partially within folder 404 and sleeve 406prior to deployment, whereby the extension portion 202 of device 200 maybe positioned within at least part of folder 404, and whereby the flangeportion 204 of device 200 may be positioned within at least part of asleeve 406 (as shown in FIG. 4).

As shown in FIG. 5A, device 200 may be partially deployed as follows.First, and in an exemplary method of positioning a stent within a body,a wire 500 (a guide wire, for example) may be advanced within a body ator near a desired location of device 200 deployment. When wire 500 hasbeen advanced, hypotube 402, along with any portions of system 400coupled to hypotube, may be advanced along wire 500 within the body. Asshown in FIG. 4, initial advancement of at least a portion of system 400may comprise advancement of hypotube 402, folder 404, sleeve 406, anddevice 200 positioned within folder 404 and sleeve 406.

When device 200 has been positioned within a body at or near a desiredposition, sleeve 406 may be withdrawn toward the proximal end ofhypotube 402 (in the direction of the arrow shown in the figure). Thisstep may be performed prior to, during, or after the step of positioningthe distal end of hypotube 402 within a vessel (for example, a vesselbranching off the aortic arch 104). As sleeve 406 is slid toward theproximal end of hypotube 402, the flange portion 204 of device 200 isallowed to expand as shown in FIG. 5A.

Further deployment of device 200 within a body is shown in FIG. 5B. Asshown in FIG. 5B, and upon movement of folder 404 away from device 200(in a direction shown by the arrow in the figure, for example),extension portion 202 of device 200 may deploy as shown in FIG. 5B. Asfolder 404 is moved away from device 200 (by, for example, advancementof hypotube 402 within a body), extension portion 202 of device 200 isno longer positioned within folder 404, thereby permittingexpansion/deployment of extension portion 202.

FIGS. 6A and 6B show exemplary embodiments of at least a portion of asystem for preventing stroke. In at least one embodiment, system 400comprises a conical dilator 600 slidingly engaged around a hypotube 402coupled to a folder 404. As shown in FIG. 6A, an exemplary conicaldilator 600 may comprise a tapered distal end 602, wherein the tapereddistal end 602 is sized and shaped to engage the inside of folder 404.To engage folder 404, conical dilator 600 may slide along hypotube 402in a direction indicated by the arrow in FIG. 6A. An exemplaryembodiment of the engagement of conical dilator 600 and folder 404 isshown in FIG. 6B.

Engagement of conical dilator 600 with folder 404, as shown in FIGS. 6Aand 6B, may facilitate the removal of at least a portion of system 400from a body after positioning device 200. For example, and as shown inFIGS. 5A and 5B, after deployment of device 200 within a body, theportion of system 400 comprising folder 404 is positioned, for example,further within a vessel than device 200. Removal of the portion of thesystem 400 comprising hypotube 402 and folder 404 would require, forexample, pulling that portion of system 400 back through device 200. Asshown in the exemplary embodiments of FIGS. 5A-6B, folder 404 may, forexample, become caught on device 200 and/or a portion of a body,preventing effective removal of that portion of system 400.

In at least one embodiment, and by engaging folder 404 with conicaldilator 600, folder 404, along with the portion of system 400 coupled tofolder 404, may be removed from a body after placement of a device 200as shown in FIGS. 7A and 7B. As shown in FIG. 7A, and after a device 200has been deployed, a user of system 400 may slide a conical dilator 600along hypotube 402 in a direction indicated by the arrow. Conicaldilator 600, in the example shown in FIGS. 7A and 7B, would be sized andshaped as to fit within the spaces between convex struts 212 of device200. After conical dilator 600 has engaged folder 404, as shown in FIG.7B, hypotube 402 may be withdrawn from the body in a direction indicatedby the arrow, and because of the engagement, folder 404 may be removedfrom the body without becoming caught on device 200.

In at least one embodiment of a system for preventing stroke of thepresent disclosure, system 400 comprises a device 200, a hypotube 402,and a folder 404 coupled to hypotube 402 at or near the distal end ofhypotube 402. Device 200, in at least one embodiment, may beautoexpandable, i.e. device 200 has a “memory” allowing it to expand toa native configuration after being retracted/compressed to fit within,for example, folder 404 and sleeve 406. System 400, in at least oneembodiment, may further comprise, or be used in connection with, afemoral catheterization kit known and used in the marketplace.

In at least one exemplary method of positioning device 200 within a bodyof the present disclosure, the percutaneous placement of thepercutaneous carotid emboli rerouting device (device 200) may beperformed in an angiography procedure room. Prior to positioning device200, a user may perform a contrast aortogram, for example, to map outthe aortic arch 104 and where the cerebral vessels merge with aorticarch 104. For safety, patient preparation and sterile precautions arerecommended as for any angioplasty procedure.

In at least one embodiment of a method for preventing stroke, the methodcomprises the step of performing a percutaneous angiogram usingtechnique(s) known in the art under local anesthesia. As referencedabove, the percutaneous angiogram would map the aortic arch 104 so thata user of a device 200 and/or system 400 of the disclosure of thepresent application would, for example, be able to select anappropriately-sized device 200 and/or system 400 (or portion(s) thereof)when performing the procedure. A user may also introduce a wire 500(such as guide wire as shown in FIG. 5A) to reach the innominate artery114 and/or the left common carotid artery 116. After wire 500 has beenpositioned, portions of system 400 may be mounted over the guide wireand progressed to the level of the entrance of the innominate artery 114and/or the left common carotid artery 116. Said portions of system 400may include hypotube 402 and a folder 404 distally mounted thereto, andmay further comprise a sleeve 406, wherein an exemplary device 200 maybe positioned at least partially within folder 404 and sleeve 406, asshown in FIG. 8A.

Deployment of device 200, in an exemplary embodiment of a method of thepresent application for performing the same, is as a follows. Underfluoroscopy, sleeve 406 may be pulled back to allow the delivery of theproximal portion of the stent (the flange portion 204 of device 200) asshown in FIG. 8B. The diameter of flange portion 204 that exceeds thediameter of the innominate artery 114 and/or the left common carotidartery 116 impedes the progression of device 200 within said arteries,thus giving the user/operator time to deliver and anchor the secondportion of the stent (the extension portion 202 of device 200), by, forexample, forward progression of hypotube 402 as shown in FIGS. 5B and8C. When device 200 has been positioned, removal of hypotube 402 andfolder 404 may be removed from the body, for example, by introducingconical dilator 600 as described herein. In at least one example, thetapered distal end 602 of conical dilator 600 is advanced until itengages folder 404 of hypotube 402, as shown in FIGS. 6A-7B, 8D and 8E,effectively forming a single unit (conical dilator 600+hypotube402+optionally wire 500 (not shown)). This “unit” may then removedthrough the convex struts 212 as shown in FIG. 8E, and distally to thefemoral artery for which at least part of system 400 was initiallyintroduced.

The various devices, systems, and methods for preventing stroke of thepresent disclosure have various benefits to patients with variousdiseases and/or disorders of the heart and/or circulatory system. Forexample, patients with chronic atrial fibrillation (non-valvular atrialfibrillation), recurrence transient ischemic attack, atrial fibrillationand anticoagulation contraindications, and/or left atrial appendagethrombosis may have their risk of stroke either reduced or eliminated byway of an exemplary devices, systems, and/or method of the presentdisclosure. In addition, patients with acute myocardial infarct withleft ventricular thrombus, atrial flutter (ablation and pulmonary veinisolation), cardiomyopathy with left ventricular enlargement,non-obstructive thrombus of a mechanical heart valve, patent foramenovale (cryptogenic ischemic stroke) and/or an acute infectionendocardiatis with valve vegetation without valve insufficiency undermedical treatment (vegetation>1 cm which currently oblige to surgicalremotion) may also benefit from the present disclosure.

While various embodiments of devices, systems, and methods for theprevention of stroke have been described in considerable detail herein,the embodiments are merely offered by way of non-limiting examples ofthe disclosure described herein. It will therefore be understood thatvarious changes and modifications may be made, and equivalents may besubstituted for elements thereof, without departing from the scope ofthe disclosure. Indeed, this disclosure is not intended to be exhaustiveor to limit the scope of the disclosure.

Further, in describing representative embodiments, the disclosure mayhave presented a method and/or process as a particular sequence ofsteps. However, to the extent that the method or process does not relyon the particular order of steps set forth herein, the method or processshould not be limited to the particular sequence of steps described.Other sequences of steps may be possible. Therefore, the particularorder of the steps disclosed herein should not be construed aslimitations of the present disclosure. In addition, disclosure directedto a method and/or process should not be limited to the performance oftheir steps in the order written. Such sequences may be varied and stillremain within the scope of the present disclosure.

1. A device for the prevention of stroke, the device comprising: anextension portion sized and shaped to fit within an artery extendingfrom an aortic arch; and a flange portion sized and shaped to preventthe device from advancing into the artery extending from the aortic archin which the device may be positioned, the flange portion comprising twoor more parallel convex struts positioned across an opening definedwithin the flange portion, the two or more parallel convex strutscapable of diverting an embolus from entering the artery when the deviceis positioned within the artery.
 2. The device of claim 1, wherein thetwo or more parallel convex struts comprises four or more parallelconvex struts.
 3. The device of claim 1, wherein when the device ispositioned within the artery extending from an aortic arch, the two ormore parallel convex struts are positioned approximately perpendicularto a direction of blood flow within the aortic arch.
 4. The device ofclaim 1, wherein when the device is positioned within the arteryextending from an aortic arch, the two or more parallel convex strutsare positioned in a direction of blood flow within the aortic arch. 5.The device of claim 1, wherein the device comprises a stent.
 6. Thedevice of claim 5, wherein the stent is autoexpandable.
 7. The device ofclaim 1, wherein the extension portion comprises a substantiallycylindrical shape.
 8. The device of claim 1, wherein the extensionportion comprises an extension mesh comprising multiple wires.
 9. Thedevice of claim 1, wherein the extension portion has a length betweenabout 1.5 cm to about 2.5 cm.
 10. The device of claim 1, wherein theextension portion has a diameter between about 6 mm to about 8 mm whenthe extension portion is in an expanded configuration.
 11. The device ofclaim 1, wherein the extension portion has a diameter between about 1.8mm to about 2.0 mm when the extension portion is in a compressedconfiguration.
 12. The device of claim 1, wherein the device iscomprised of a material selected from the group consisting of stainlesssteel, cobalt-chromium-nickel-molybdenum-iron alloy, tantalum, nitinol,nickel-titanium, polymer materials, and a shape-memory polymer.
 13. Thedevice of claim 1, wherein the flange portion comprises a flange meshcomprising multiple wires.
 14. The device of claim 1, wherein the flangeportion comprises a planar flange.
 15. The device of claim 1, furthercomprising: one or more radiopaque markers positioned upon the flangeportion.
 16. The device of claim 15, wherein the one or more radiopaquemarkers are positioned relative to the two or more parallel convexstruts.
 17. The device of claim 15, wherein when the device positionedwithin the artery extending from an aortic arch, the one or moreradiopaque markers facilitate alignment of the device so that the two ormore parallel convex struts are positioned approximately perpendicularto a direction of blood flow within the aortic arch.
 18. The device ofclaim 15, wherein when the device positioned within the artery extendingfrom an aortic arch, the one or more radiopaque markers facilitatealignment of the device so that the two or more parallel convex strutsare positioned in a direction of blood flow within the aortic arch. 19.The device of claim 1, wherein the diameter of each of the two or moreparallel convex struts is between about 0.25 mm and 0.5 mm.
 20. Thedevice of claim 2, wherein the two or more parallel convex struts arepositioned between about 0.5 mm to 1.5 mm from one another.
 21. Thedevice of claim 1, wherein the two or more parallel convex struts areflexible.
 22. A device for the prevention of stroke, the devicecomprising: an extension portion sized and shaped to fit within anartery extending from an aortic arch; and a flange portion sized andshaped to prevent the device from advancing into the artery extendingfrom the aortic arch in which the device may be positioned, the flangeportion capable of diverting an embolus from entering the arteryextending from the aortic arch when the device is positioned within theartery. 23.-41. (canceled)
 42. A device for the prevention of stroke,the device comprising: an extension portion comprising a substantiallycylindrical shape, the extension portion sized and shaped to fit withinan artery extending from an aortic arch; a flange portion sized andshaped to prevent the device from advancing into the artery extendingfrom the aortic arch in which the device may be positioned, the flangeportion comprising two or more parallel convex struts positioned acrossan opening defined within the flange portion, the two or more parallelconvex struts capable of diverting an embolus from entering the arterywhen the device is positioned within the artery; and one or moreradiopaque markers positioned upon the flange portion, wherein when thedevice positioned within the artery extending from an aortic arch, theone or more radiopaque markers facilitate alignment of the device sothat the two or more parallel convex struts are positioned approximatelyperpendicular to a direction of blood flow within the aortic arch. 43.The device of claim 42, wherein the diameter of each of the two or moreparallel convex struts is between about 0.25 mm and 0.5 mm, and whereinthe two or more parallel convex struts are positioned between about 0.5mm to 1.5 mm from one another.
 44. A device for the prevention ofstroke, the device comprising: an extension portion comprising asubstantially cylindrical shape, the extension portion sized and shapedto fit within an artery extending from an aortic arch; a flange portionsized and shaped to prevent the device from advancing into the arteryextending from the aortic arch in which the device may be positioned,the flange portion comprising two or more parallel convex strutspositioned across an opening defined within the flange portion, the twoor more parallel convex struts capable of diverting an embolus fromentering the artery when the device is positioned within the artery; andone or more radiopaque markers positioned upon the flange portion,wherein when the device positioned within the artery extending from anaortic arch, the one or more radiopaque markers facilitate alignment ofthe device so that the two or more parallel convex struts are positionedin a direction of blood flow within the aortic arch.
 45. The device ofclaim 44, wherein the diameter of each of the two or more parallelconvex struts is between about 0.25 mm and 0.5 mm, and wherein the twoor more parallel convex struts are positioned between about 0.5 mm to1.5 mm from one another. 46.-87. (canceled)